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Community-Based Maintenance Exercise Program for COPD

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ClinicalTrials.gov Identifier: NCT01942499
Recruitment Status : Recruiting
First Posted : September 16, 2013
Last Update Posted : May 10, 2017
Sponsor:
Collaborators:
Ontario Lung Association
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Roger Goldstein, West Park Healthcare Centre

Brief Summary:

It is well established that individuals living with chronic obstructive pulmonary disease (COPD) demonstrate significant improvements following a formal rehabilitation program. The problem lies in the fact that these functional improvements diminish over a 12 month period. This decline in function is associated with decreased participation, a decline in health status, and an increased need to access the healthcare system. The objective of this project is to evaluate the effectiveness of a post-rehabilitation community-based exercise program for individuals with COPD and compare the outcomes with those achieved through standard care.

Individuals with COPD who have completed a previous rehabilitation program will be enrolled in the study. Study participants will be assigned randomly to either a year-long community exercise program or usual care. Those assigned to the community program will exercise twice weekly at a local community centre supervised by trained fitness instructors. A case manager will facilitate the transition from the hospital rehabilitation program to the community centre. The case manager will also be available to participants and instructors for consult as needed. Continuing to build on an established partnership with the City of Toronto, the case manager will ensure fitness instructors receive specialized training in order to properly supervise and support the individuals with COPD. Participants assigned to usual care group will receive standard care by their family physician and respiratory specialist. Functional status will be evaluated before the program begins and again at 6-months and 1-year. The outcome of each group will be compared to determine the effectiveness of the community exercise program. It is hypothesized that individuals who participate in the community exercise program will have better function and quality of life versus those individuals who receive standard care.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Community-based exercise program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of a Post-rehabilitation Community-based Exercise Program for Individuals With COPD
Study Start Date : November 2012
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Community Exercise Group
Community-based exercise program for one year
Other: Community-based exercise program
No Intervention: Usual Care



Primary Outcome Measures :
  1. Change from baseline in Six Minute Walk Test at 6 months [ Time Frame: Baseline and 6 months ]
  2. Change from baseline in Six Minute Walk Test at 12 months [ Time Frame: Baseline and 12 months ]

Secondary Outcome Measures :
  1. Change from baseline in Chronic Respiratory Disease Questionnaire at 6 months [ Time Frame: Baseline and 6 months ]
  2. Change from baseline in Repeated Chair Stand at 6 months [ Time Frame: Baseline and 6 months ]
  3. Change from baseline in Duke Activity Status Index at 6 months [ Time Frame: Baseline and 6 months ]
  4. Change from baseline in Health Utilities Index at 6 months [ Time Frame: Baseline and 6 months ]
  5. Change in baseline in COPD Self-Efficacy Scale at 6 months [ Time Frame: Baseline and 6 months ]
  6. Change from baseline in Chronic Respiratory Disease Questionnaire at 12 months [ Time Frame: Baseline and 12 months ]
  7. Change from baseline in Duke Activity Status Index at 12 months [ Time Frame: Baseline and 12 months ]
  8. Change from baseline in Health Utilities Index at 12 months [ Time Frame: Baseline and 12 months ]
  9. Change from baseline in Repeated Chair Stand at 12 months [ Time Frame: Baseline and 12 months ]
  10. Change in baseline in COPD Self-Efficacy Scale at 12 months [ Time Frame: Baseline and 12 months ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • individuals with moderate to severe COPD based on international (GOLD) criteria
  • clinically stable
  • able to provide their own informed consent
  • able to secure independent transportation to the community site

Exclusion Criteria:

  • individuals with associated medical conditions that limit their exercise tolerance (cardiovascular, musculo-skeletal, recent surgery, etc.)
  • individuals who report a history of significant cardiovascular disease (i.e. congestive cardiac failure, history of cardiac arrest, acute myocardial infarction within the preceding three months, symptomatic ischaemic cardiac disease, uncontrolled systemic hypertension) or report severe non-respiratory symptoms during exercise
  • individuals receiving mechanical ventilation
  • individuals who are unable to attend the community-based exercise program or follow-up assessment sessions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942499


Contacts
Contact: Annemarie Lee, PhD 1 (416) 243-3600 ext 2653 annemarie.lee@westpark.org
Contact: Dina Brooks, PhD 1 (416) 243-3600 ext 2636 dina.brooks@utoronto.ca

Locations
Canada, Ontario
Trillium Health Partners- Credit Valley Hospital Recruiting
Mississauga, Ontario, Canada, L5M 2N1
Contact: Deb Coutts, RRT    905-813-1100 ext 6720    debbie.coutts@trilliumhealthpartners.ca   
Sub-Investigator: Frank Ritacca, MD         
Principal Investigator: Dina Brooks, PhD         
St. Joseph's Care Group Recruiting
Thunder Bay, Ontario, Canada, P7A 4J2
Contact: Shelley Prevost, RT    807-343-2431    prevosts@tbh.net   
West Park Healthcare Centre Recruiting
Toronto, Ontario, Canada, M6M 2J5
Contact: Annemarie Lee, PhD    1 (416) 243-3600    annemarie.lee@westpark.org   
Sub-Investigator: Annemarie Lee, PhD         
Principal Investigator: Dina Brooks, PhD, MSc, BScPT         
Principal Investigator: Roger Goldstein, MD         
Lakeridge Health Recruiting
Whitby, Ontario, Canada, L1N5T2
Contact: Darrell VanderSlagt, BScPT    905-668-6831 ext 3097    dvanderslagt@lakeridgehealth.on.ca   
Principal Investigator: Darrell VanderSlagt, BScPT         
Sponsors and Collaborators
West Park Healthcare Centre
Ontario Lung Association
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Roger Goldstein, MD West Park Healthcare Centre

Responsible Party: Roger Goldstein, Respirologist, West Park Healthcare Centre
ClinicalTrials.gov Identifier: NCT01942499     History of Changes
Other Study ID Numbers: 12-006-WP
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

Keywords provided by Roger Goldstein, West Park Healthcare Centre:
COPD, exercise, community

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases